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No Treatment-Emergent Issues Found After Switching From Infliximab to SB2
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WASHINGTON — An international group of researchers found no treatment-emergent issues or clinically relevant immunogenicity among patients who switched from infliximab to its biosimilar SB2, according to findings presented at the American College of Rheumatology Annual Meeting.
Josef S. Smolen, MD, in the Division of Rheumatology at the Medical University of Vienna, and colleagues performed a double-blinded phase 3 transition study. They randomized patients 1:1 to receive either SB2 or infliximab at weeks 0, 2, 6 and then every 8 weeks thereafter until week 46. After 54 weeks, patients who received infliximab were randomized to receive either SB2 (n = 94) or continue infliximab (n = 101) until week 70. In addition, patients who received SB2 continued to receive SB2 until week 70 (n = 201). The researchers assessed safety, immunogenicity and efficacy up to week 78.
The safety profile between the patients who transitioned from infliximab to SB2 (INF/SB2) was comparable to the safety profile of those who stayed with infliximab (INF/INF) and those who started and stayed with SB2 (SB2/SB2). During the transition period, the adverse event rate was 36.2% for INF/SB2; 35.6% for INF/INF; and 40.3% for SB2/SB2. In addition, the incidence of infusion-related reaction was 3.2%, 2% and 3.5%, respectively. Patients who had negative anti-drug antibodies (ADA) after 54 weeks developed new ADAs in 14.6% of the INF/SB2 group, in 14.9% of the INF/INF group and in 14.1% of the SB2/SB2 group. According to the researchers, efficacy was sustained and comparable between groups. – by Will Offit
Reference:
Smolen JS, et al. Abstract #2596. Presented at: American College of Rheumatology Annual Meeting; Nov. 11-16, 2016; Washington.
Disclosures: Smolen reports he received consulting fees from AbbVie, Janssen, MSD, Pfizer, Roche, UCB, Amgen, AstraZeneca, Astro-Pharma, Celgene, GSK, Lilly, MedImmune, Novartis-Sandoz, Novo Nordisk, Samsung Bioepis and Sanofi. Please see the abstract for a list of all other relevant financial disclosures.